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NCT Number: NCT07504900

Dysphagia Risk in Rheumatic Diseases

This study aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, Kınıklı, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a diagnosis of a rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, etc.)
  • Being 18 years of age or older
  • Having the cognitive ability to answer the questionnaires
  • Volunteering to participate in the study

Exclusion criteria

  • Having any neurological or psychological disorder that may prevent participation
  • Having a psychiatric disorder severe enough to affect cooperation
  • Being hospitalized during an acute flare
  • History of active gastrointestinal surgery within the last 3 months

Treatment and study plan

Primary outcomes

  1. Eating Assessment Tool (EAT-10)

    Time frame: at baseline

    The primary outcome is the risk of dysphagia in patients with inflammatory rheumatic diseases, measured using a validated questionnaire administered once to each participant. The swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The scale consists of 10 items, with a total score ranging from 0 to 40. Higher scores indicate a greater severity of swallowing impairment (a score of ≥3 is considered indicative of dysphagia)

  2. Fonseca Anamnestic Questionnaire

    Time frame: at baseline

    The severity of temporomandibular disorders was assessed using the Fonseca Anamnestic Index (FAI). The index consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate a greater severity of temporomandibular dysfunction

  3. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: at baseline

    Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items scored on a 7-point Likert scale ranging from 1 to 7. Total and subscale scores are calculated, where higher scores indicate greater symptom severity and a worse clinical condition.

  4. Functional Oral Intake Scale (FOIS)

    Time frame: at baseline

    The patient's functional level of oral intake was assessed using the Functional Oral Intake Scale (FOIS). The scale is a 7-point ordinal scale with scores ranging from 1 to 7. Unlike many other clinical tools, higher scores on the FOIS indicate better functional oral intake, with a score of 1 representing total tube dependency and a score of 7 representing total oral intake with no restrictions.

  5. Mediterranean Diet Quality Index (KIDMED)

    Time frame: at baseline

    Nutritional habits and adherence to the Mediterranean diet were evaluated using the Mediterranean Diet Quality Index (KIDMED). The index is based on a 16-item questionnaire with total scores ranging from -4 to 12. Higher scores indicate better adherence to the Mediterranean diet and higher dietary quality.

  6. Reflux Symptom Index (RSI)

    Time frame: at baseline

    The severity of laryngopharyngeal reflux symptoms was assessed using the Reflux Symptom Index (RSI). The index is a 9-item self-reported questionnaire with a total score ranging from 0 to 45. Higher scores indicate a greater severity of symptoms, with a score of 13 or higher typically considered as clinically significant for reflux.

  7. Malnutrition Inflammation Score

    Time frame: at baseline

    Nutritional status and inflammation levels were assessed using the Malnutrition-Inflammation Score (MIS). The score consists of 10 components, including clinical history, physical examination, body mass index, and laboratory parameters (serum albumin and total iron-binding capacity). Each component is scored from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate a greater severity of malnutrition and inflammation.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Assessment of Dysphagia Risk in Individuals With Inflammatory Rheumatic Diseases

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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